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The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are rapid chromatographic immunoassays for the qualitative detection of methadone in urine at a cut-off concentration of 300 ng/mL. They are intended for professional and healthcare professional use.

The ACON MTD One Step Methadone Test Strip and ACON MTD One Step Methadone Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of methadone in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the antibody to selectively detect elevated levels of methadone in urine at a cut-off concentration of 300 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing methadone at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the provided text regarding the ACON MTD One Step Methadone Test Strip and Device, focusing on the requested information:

Acceptance Criteria and Study Details for ACON MTD One Step Methadone Test

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria for the agreement percentages. However, based on the presented results and the conclusion of substantial equivalence, the implicit acceptance criteria would have likely been high agreement percentages with both the predicate device and the GC/MS reference method. The reported performance is as follows:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 300 clinical urine specimens.
  • This included 10% of samples with methadone concentrations at -25% of the cut-off range.
• Data Provenance: The text states "clinical urine specimens," implying these were collected from a clinical setting.
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Not specified, but generally, studies comparing against established methods using collected samples are retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. The ground truth for the test set was established by objective laboratory methods (GC/MS and comparison to a predicate device), not by expert interpretation of the test device itself.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The study compares the device's results directly against a predicate device and a reference laboratory method (GC/MS). Discrepancies would be resolved by the reference method, not by an adjudication panel interpreting the device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the device itself against established methods, not on how human readers would perform with or without AI assistance, as these are qualitative immunoassay tests read visually.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Yes, this was a standalone performance study. The ACON MTD One Step Methadone Test Strip and Device are described as "rapid chromatographic immunoassays" with a "visual, qualitative end result" that "can be performed without the use of an instrument." The performance data presented are for the device's ability to detect methadone in urine, independent of human interpretive variability beyond simply reading a positive/negative line.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • Predicate Device Comparison: The LifeSign Status DS™ MTD One-Step Methadone Test (K991080), a previously cleared device.
  • Objective Laboratory Method: Gas Chromatography/Mass Spectrometry (GC/MS) analysis at a cut-off of 300 ng/mL. GC/MS is considered a gold standard for confirming drug presence and concentration.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not specified. As this is a test kit (immunoassay) rather than a complex algorithm requiring machine learning, there might not be a distinct "training set" in the conventional sense of algorithm development. The design and optimization of the test kit itself would have been part of development, but specific training set data for performance claims are not relevant here.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of a traditional "training set" for an algorithm. The development of the test would involve internal validation and optimization using known positive and negative samples, but these are typically not documented as separate "ground truth" establishment for a training set in a 510(k) summary for this type of device.

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